FDA 510(k)

POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K-Number: K080794 · 2008-12-17

Decision Date2008-12-17

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR is the device name listed in this FDA 510(k) record. The listed applicant is Polyvue Distribution, Inc.. It received FDA 510(k) clearance on 2008-12-17 under 510(k) number K080794. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR?

POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR is a medical device that received FDA 510(k) clearance on 2008-12-17. The listed applicant is Polyvue Distribution, Inc.. The 510(k) number is K080794.

When did POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR receive FDA 510(k) clearance?

POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR received FDA 510(k) clearance on 2008-12-17, under 510(k) number K080794.

Who is the listed applicant for POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR?

The FDA 510(k) record lists Polyvue Distribution, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR?

The FDA product code for POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR is LPL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.